Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy of 2LHERP® in Patients With Recurrent Genital Herpes Infections
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 11
- 主要终点
- Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent genital herpes infections at 12 months compare to placebo.
研究概览
简要总结
Herpes simplex virus (HSV) infection is very common, as most people will experience herpetic infection during their lifetime. The most common manifestation of HSV infection is sores which may appear at any age. No specific antiviral therapy is available to totally cure herpetic infections and today, there is no treatment that allows the definitive eradication of the virus.
The 2LHERP® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of herpetic infections. Since 2LHERP® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the disappearance of herpetic recurrences.
The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LHERP® on the treatment of herpetic infections in adults.
详细描述
The study duration will be maximum 45 months with 33 months of inclusion and 12 months of follow-up. Patients aged between 18 and 80 years who present recurrent genital herpes infections (4 or more episodes within the 12-months' period prior to their study entry). The total number of patients to include will be 100 with 50 patients per group.
Primary objective:
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent genital herpes infections at 12 months compare to placebo.
Secondary objectives:
Comparison of the efficacy of 2LHERP® vs placebo, according to the following aspects:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman aged 18-80 years,
- •Patient presenting 4 or more episodes of genital herpes infections during the preceding 12-months' period (prior to the study entry),
- •Woman of childbearing age under effective contraception,
- •Patient reporting a current stable sexual relationship (steady sexual partner during study duration),
- •Patient having faculties to understand and respect the constraints of the study,
- •Signature of the Informed Consent Form.
排除标准
- •Pregnant or breastfeeding woman,
- •Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months,
- •Patient who had a suppressive antiviral therapy during last month,
- •Patient who wishes to continue his/her suppressive antiviral therapy,
- •Patient with known lactose intolerance,
- •Patient who participated in a clinical study in the previous 3-month period,
- •Patient who is not sufficiently motivated to engage in a follow-up period of 12 months, or likely to travel or to move before the end of the study,
- •Patient with severe immunodeficiency disease requiring long term treatment (*) or under chemotherapy or radiotherapy or corticoid therapy,
- •Patient under listed homeopathic or phytotherapy treatment,
- •Patient using or addicted to recreational drugs.
- •(*) important renal or respiratory insufficiency, transplanted or grafted patients, HIV/AIDS, terminal cancer.
研究组 & 干预措施
2LHERP® arm
2LHERP® treatment (6 months of treatment)
干预措施: 2LHERP® (Drug)
Placebo arm
Placebo treatment (6 months of treatment)
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent genital herpes infections at 12 months compare to placebo.
时间窗: 12 months
Change from baseline within the number of episodes of genital herpes infection observed for 12 months, where the baseline value is the number of episodes experienced within the 12 months preceeding study enrolment.
次要结局
- Comparison of the efficacy of 2LHERP® versus placebo according to the number of episodes at 6 months.(6 months)
- Comparison of the efficacy of 2LHERP® versus placebo according to - remaining herpes infection recurrence free 6 and 12 months after the treatment initiation(6 and 12 months)
- Comparison of the efficacy of 2LHERP® versus placebo according to the time to first episode during the treatment(6 months)
- Comparison of the efficacy of 2LHERP® versus placebo according to the duration of episodes(6 and 12 months)
- Comparison of the efficacy of 2LHERP® versus placebo according to the symptomatology during the entire relapse time(6 and 12 months)
- Comparison of the efficacy of 2LHERP® versus placebo according to the evaluation of impact on the quality of life(6 and 12 months)
- Comparison of the efficacy of 2LHERP® versus placebo according to safety issues(6 months)
- Comparison of the efficacy of 2LHERP® versus placebo according to the use of Rescue Medication(6 and 12 months)